Enders Martin, Bartelt Uwe, Knotek Frank, Bunn Kristina, Strobel Sirpa, Dietz Klaus, Enders Gisela
Laboratory Prof. Gisela Enders and Colleagues, MVZ, Stuttgart, Germany.
Clin Vaccine Immunol. 2013 Mar;20(3):420-6. doi: 10.1128/CVI.00688-12. Epub 2013 Jan 23.
Rubella in early pregnancy bears a high risk for congenital defects (e.g., cataracts, hearing loss, and heart disease) and for long-term sequelae in the newborn. Despite implementation of vaccination programs in many regions, the threat of devastating consequences from congenital rubella virus infection remains and careful screening of maternal immune status before and during pregnancy helps to reduce the risk. This study compared the performance of the Elecsys Rubella IgG assay with that of other assays routinely used for screening. Samples from 1,090 women undergoing routine antenatal care were tested using the Elecsys and Enzygnost Rubella IgG assays and the hemagglutination inhibition test. Samples with hemagglutination inhibition titers of <32 (n = 148) were additionally tested using the Vidas, AxSYM, Liaison, and Architect Rubella IgG assays. Agreement of qualitative results from the Elecsys, Enzygnost, and hemagglutination inhibition assays was good in all samples. All assays showed 100.0% specificity. In samples with hemagglutination inhibition titers of <32, the Elecsys, AxSYM, and Enzygnost assays showed higher sensitivity (>90.0%) than the other immunoassays (78.6 to 82.4%). The Elecsys assay reported significantly higher rubella virus IgG levels than the other immunoassays across the whole set of 1,090 samples, with the largest bias and deviation from limits of agreement in Bland-Altman analysis. In conclusion, the Elecsys assay is highly sensitive and specific with regard to qualitative results and suitable for routine automated screening. However, given the considerable variation between quantitative results from different immunoassays, testing methods should be documented and the same assay used throughout an individual's antenatal follow-up wherever possible.
孕早期感染风疹会使胎儿出现先天性缺陷（如白内障、听力丧失和心脏病）以及新生儿长期后遗症的风险很高。尽管许多地区实施了疫苗接种计划，但先天性风疹病毒感染带来的毁灭性后果的威胁依然存在，孕期前后仔细筛查孕妇免疫状态有助于降低风险。本研究比较了Elecsys风疹IgG检测法与其他常规用于筛查的检测法的性能。对1090名接受常规产前检查的女性的样本进行了Elecsys和Enzygnost风疹IgG检测法以及血凝抑制试验检测。血凝抑制效价<32（n = 148）的样本还使用Vidas、AxSYM、Liaison和Architect风疹IgG检测法进行了检测。Elecsys、Enzygnost和血凝抑制试验的定性结果在所有样本中一致性良好。所有检测法的特异性均为100.0%。在血凝抑制效价<32的样本中，Elecsys、AxSYM和Enzygnost检测法的灵敏度（>90.0%）高于其他免疫检测法（78.6%至82.4%）。在全部1090个样本中，Elecsys检测法报告的风疹病毒IgG水平显著高于其他免疫检测法，在Bland-Altman分析中偏差最大且偏离一致性界限。总之，Elecsys检测法定性结果的灵敏度和特异性很高，适合常规自动化筛查。然而，鉴于不同免疫检测法定量结果存在较大差异，检测方法应记录在案，并且在个体产前随访过程中尽可能使用同一种检测法。
